Transpulmonary Driving Pressure and Intra-abdominal Pressure Relationship During Laparoscopic Surgery

NCT03435913 — Not applicable, Completed, 30 participants, Hospital Universitario La Fe

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Assessment of Transpulmonary Driving Pressure and Intra-abdominal Pressure Relationship at Different Levels of Positive End-expiratory Pressure (PEEP) During Laparoscopic Surgery

Registry	NCT03435913
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, single group, masking: none, diagnostic
Enrollment	30 (Actual)
Sponsor	Hospital Universitario La Fe (Other)
Conditions	Anesthesia, General/Methods, Laparoscopy, Respiration, Artificial, Positive-Pressure Respiration, End-Expiratory Pressure, Positive, Ventilator-Induced Lung Injury
Interventions	Standard PEEP ventilation, Matched PEEP ventilation (Other)
Dates	start 2018-04-19, primary completion 2018-11-21, completion 2018-11-21, first posted 2018-02-19, last updated 2019-12-17
Locations	1 site in Spain

-Summary

Objective: The aim of this project is to evaluate how intra-abdominal pressure paired coupled with different ventilatory positive end-expiratory pressure levels affects the transpulmonary driving pressure during pneumoperiteneum insufflation for laparoscopic surgery.

Methodology: Patients undergoing laparoscopic surgery will be included. The study will investigate the relationship between intra-abdominal pressure (IAP) and transpulmonary driving pressure (TpDp) and the effect of titration of PEEP on their relationship.

At three different levels of intra-abdominal pressure, the respiratory driving pressure (RDp) and TpDp in each subject will be measured in each subject. The same subject will undergo two different ventilation strategies. Demographic data (height, weight, body mass index and sex), ASA physical status (surgical risk classification of the American Society of Anesthesiology), number of previous abdominal surgeries, number of previous pregnancies, and respiratory comorbidities will be collected. Respiratory pressures and mechanics will be recorded at each level of intra-abdominal pressure (IAP) during each ventilatory strategy. The variables recorded will include: airway pressures (Plateau pressure Pplat, Peak pressure, Ppeak), the final esophageal pressure of inspiration and expiration and pulmonary stress index. Mixed linear regression will be used to evaluate the relationship between different PEEP levels, IAP and TpDp by adjusting for known confounders and adding individuals as a random factor. Likewise, an analysis using a mixed linear regression model with the pulmonary stress index as a function of the intra-abdominal pressure, the ventilation regime, and a specific random intercept term for each subject will be performed.

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+Arms and interventions

Arm	Type	Interventions	Description
Standard PEEP ventilation	Experimental	Other: Standard PEEP ventilation; Other: Matched PEEP ventilation	During pneumoeperitoneum insufflation the patient is ventilated with 7 ml/kg per ideal body weight, inspiration:expiration (I:E) ratio 1:2, and respiration rate (RR) to maintain EtCO2 at 35-38 mmHg and 5 cmH20 of PEEP at every intra-abdominal pressure (IAP) step (8, 12 and 15 mmHg).
Matched PEEP Ventilation	Experimental	Other: Standard PEEP ventilation; Other: Matched PEEP ventilation	During pneumoeperitoneum insufflation the patient is ventilated with 7 ml/kg per ideal body weight, inspiration:expiration (I:E) ratio 1:2, and respiration rate (RR) to maintain EtCO2 at 35-38 mmHg and a level of PEEP matched to every IAP step (8, 12 and 15 mmHg). 1 mmHg = 1,36 cmH20. Between the standard and matched PEEP intervention there is a washout period that with a recruitment maneuver to re-establish baseline lung condition.

Standard PEEP ventilation (Other): During mechanical ventilation a fixed PEEP (5 mcH2O) is set at all IAP levels during pneumoperitoneum insufflation
Matched PEEP ventilation (Other): During mechanical ventilation PEEP is matched to IAP level

+Outcome measures

Primary outcomes

Transpulmonary driving pressure (TpDp) difference between standard and matched PEEP ventilation [Pneumoperitoneum insufflation before surgery (up to 30 minutes)]: TpDp (assessed in centimeters of water, cmH20) as assessed by ventilatory pressure and pleural pressure (recorded by an esophageal probe) is recorded at every intra-abdominal pressure level during pneumoperitoneum insufflation. The primary outcome is the difference between a standard perioperative management (fixed PEEP + 15 mmHg pneumoperitoneum pressure) and matched PEEP to intra-abdominal pressure and 8mmHg intra-abdominal pressure

Secondary outcomes

Transpulmonary driving pressure and intra-abdmominal pressure relationship (multivariate adaptive linear regression) [Pneumoperitoneum insufflation before surgery (up to 30 minutes)]: TpDp (in cmH20) is recorded at different levels of IAP and with two different PEEP settings (in cmH20; two levels are: fixed at each IAP level, standard group and matched at each IAP level, matched group). The relationship between TpDp and IAP (both treated as continuous variables) at each PEEP level is plotted and a multiadaptive linear regression is fitted.
Transpulmonary driving pressure and respiratory driving pressure (RDp) relationship (multivariate adaptive linear regression). [Pneumoperitoneum insufflation before surgery (up to 30 minutes)]: Respiratory driving pressure (transpulmonary driving pressure + pressure to move the chest wall, in cmH20, RpDp) and TpDp relationship at each IAP and PEEP level will be assessed. The relationship between TpDp and RpDp (both treated as continuous variables) at each PEEP level is plotted and a multiadaptive linear regression is fitted.
Respiratory system compliance (Crs) difference between standard and matched PEEP levels [Pneumoperitoneum insufflation before surgery (up to 30 minutes)]: Respiratory system compliance measures the system's ability to stretch. It has two components Lung and Chest Wall (measured in milliliter/centimeters of water, ml/cmH20)
Pulmonary compliance (Cp) difference [Pneumoperitoneum insufflation before surgery (up to 30 minutes)]: Respiratory system compliance measures the system's ability to stretch (ml/cmH20). It has two components Lung and Chest Wall (measured in milliliter/centimeters of water, ml/cmH20). By using an esophageal probe measurement the two can be partitioned and analyzed separately.
Chest wall compliance (CCw) difference [Pneumoperitoneum insufflation before surgery (up to 30 minutes)]: Respiratory system compliance measures the system's ability to stretch (ml/cmH20). It has two components Lung and Chest Wall (measured in milliliter/centimeters of water, ml/cmH20). By using an esophageal probe measurement the two can be partitioned and analyzed separately.
Pulmonary Stress index difference [Pneumoperitoneum insufflation before surgery (up to 30 minutes)]: Stress index is based on respiratory pressure curve analysis and assess whether the lungs are overdistended or collapsed

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* American Society of Anesthesiology (ASA) risk scale I to III
* Age > 18 years
* Previously signed informed consent
* Undergoing laparoscopic surgery

Exclusion Criteria:

* ASA ≥ IV
* Pregnancy
* Advanced liver, kidney or cardiopulmonary disease

+Locations (1)

Facility	City	Country	Status
Hospital Universitario La Fe	Valencia	Spain

+Publications

Neto AS, Hemmes SN, Barbas CS, Beiderlinden M, Fernandez-Bustamante A, Futier E, Gajic O, El-Tahan MR, Ghamdi AA, Gunay E, Jaber S, Kokulu S, Kozian A, Licker M, Lin WQ, Maslow AD, Memtsoudis SG, Reis Miranda D, Moine P, Ng T, Paparella D, Ranieri VM, Scavonetto F, Schilling T, Selmo G, Severgnini P, Sprung J, Sundar S, Talmor D, Treschan T, Unzueta C, Weingarten TN, Wolthuis EK, Wrigge H, Amato MB, Costa EL, de Abreu MG, Pelosi P, Schultz MJ; PROVE Network Investigators. Association between driving pressure and development of postoperative pulmonary complications in patients undergoing mechanical ventilation for general anaesthesia: a meta-analysis of individual patient data. Lancet Respir Med. 2016 Apr;4(4):272-80. doi: 10.1016/S2213-2600(16)00057-6. Epub 2016 Mar 4. PMID 26947624
Cortes-Puentes GA, Gard KE, Adams AB, Faltesek KA, Anderson CP, Dries DJ, Marini JJ. Value and limitations of transpulmonary pressure calculations during intra-abdominal hypertension. Crit Care Med. 2013 Aug;41(8):1870-7. doi: 10.1097/CCM.0b013e31828a3bea. PMID 23863222
Cinnella G, Grasso S, Spadaro S, Rauseo M, Mirabella L, Salatto P, De Capraris A, Nappi L, Greco P, Dambrosio M. Effects of recruitment maneuver and positive end-expiratory pressure on respiratory mechanics and transpulmonary pressure during laparoscopic surgery. Anesthesiology. 2013 Jan;118(1):114-22. doi: 10.1097/ALN.0b013e3182746a10. PMID 23196259
D'Antini D, Rauseo M, Grasso S, Mirabella L, Camporota L, Cotoia A, Spadaro S, Fersini A, Petta R, Menga R, Sciusco A, Dambrosio M, Cinnella G. Physiological effects of the open lung approach during laparoscopic cholecystectomy: focus on driving pressure. Minerva Anestesiol. 2018 Feb;84(2):159-167. doi: 10.23736/S0375-9393.17.12042-0. Epub 2017 Jul 5. PMID 28679201

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